ES2589910T3 - Wound management - Google Patents

Abstract

An apparatus for supplying at least one agent to the site of a wound, comprising: a cloth (14, 1305, 1501, 1502) to cover the site of a wound; and a supply tube (1005, 1202, 1400) comprising a substantially T-shaped portion (1203, 1403) comprising an outlet (1007), an inlet outlet (1006, 1204) of the agent and a socket (1208 , 1404) air inlet; wherein the air inlet (1208, 1204) comprises an air filter (1009, 1206, 1405), characterized in that the air inlet (1208, 1404) allows the air inlet (1006, 1204) Agent inlet is washed and contributes to the removal of large volumes of fluid from the wound.

Description

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DESCRIPTION

Wound management

The present invention relates to an apparatus and a method for the application of topical negative pressure therapy (PNT) to wounds. In particular, but not exclusively, the present invention relates to a method and an apparatus for delivering an agent such as a medicament or moisturizing fluid through or under a pan that covers the site of a wound.

There is much prior art available regarding the provision of apparatus and methods of use thereof for the application of PNT therapy to wounds together with other therapeutic procedures designed to improve the effects of PNT therapy. Examples of such prior art include those listed and briefly described below.

PNT therapy contributes to the closure and healing of wounds by reducing tissue edema; promoting blood flow and tissue granulation; eliminating excess exudates and can reduce bacterial load and, thus, wound infection. In addition, PNT therapy allows less external alteration of the wound and promotes faster healing.

In the international patent application WO 2004/037334 of the inventors, in processing such as this, an apparatus, a wound dressing and a method for aspirating, irrigating and cleaning wounds are described. In very general terms, this invention describes the treatment of a wound by the application of topical negative pressure therapy (PNT) for wound aspiration along with the additional provision of additional fluid to irrigate and / or clean the wound, fluid that , comprising both wound exudates and irrigation fluid, is then drained through an aspiration medium and circulated through a means to separate the beneficial materials thereof from the harmful materials. Materials that are beneficial for wound healing are re-circulated through the wound dressing and materials harmful to wound healing are discarded in a bag or waste collection vessel.

In the international patent application WO 2005/04670 of the inventors, in processing such as this, an apparatus, a wound dressing and a method for aspirating, irrigating and cleaning wounds are described. Again, in very general terms, the invention described in this document uses an apparatus similar to that of WO 2004/037334 in relation to aspiration, irrigation and wound cleaning; however, it also includes the important additional step of providing a heating means to control the temperature of the beneficial material that is returned to the site of the wound or the dressing so that it is at an optimum temperature so that, for example, it has the therapeutic effect. more effective in the wound.

In the international patent application WO 2005/105180 of the inventors, in processing such as this, an apparatus and a method for aspiration, irrigation and / or wound cleaning are described. Again, in very general terms, this document describes an apparatus similar to those of the two previously mentioned documents, but with the additional step of providing a means for the delivery and application of physiologically active agents to the wound site or the dressing to promote wound healing.

However, generally the devices and the above methods are only applicable to a patient when he is hospitalized, since the device is complex, he needs people who have a specialized knowledge of how to operate and maintain the device, and it is also relatively heavy and bulky, not being adapted for easy mobility outside a hospital environment by a patient, for example.

Some patients who have relatively less serious wounds that, for example, do not require continuous hospitalization, but who nevertheless benefit from prolonged application of PNT therapy, may be treated at home or at work, as long as there is the availability of an easily transportable and maintainable PNT therapy device.

GB-A-2 307 180 describes a portable PNT therapy unit that can be carried by a patient attached to a belt or harness. However, it will be appreciated that there are limitations as to how the parameters associated with the site of a wound can be maintained.

In general, it is known that the bacterial load of the wounds may increase over time and that the wounds also dry while undergoing a negative pressure therapy of the wound. This occurs particularly when conventional wound dressings such as ALLEVYN (trade mark) are used. At present, one way to reduce infection of the wound or tissue is to regularly change the dressings that are placed on a wound or tissue. This has an impact on the patient, since changing the dressing can lead to patient discomfort, at a higher cost associated with the replacement of the dressing itself and can increase the likelihood of infection among patients.

It is known that, from time to time, it is advantageous to provide one or more agents, such as an analgesic drug, antibiotics, wound irrigation, etc., to the site of a wound. With known techniques, a dressing or a cloth held over the site of the wound to prevent infection should be removed before delivery of the

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agent, requiring a new pano or a new dressing subsequent to the introduction of the agent. Again, this can lead to patient discomfort, increases costs and increases the likelihood of cross infection.

Each of documents US6398767 and WO03 / 073970 shows how substances can be introduced at the site of a wound, but the techniques shown are complicated, can be prone to failures and disclose the use of only a limited number of agents.

WO 01/37922 discloses a control system for use with a bandage under negative pressure so that fluid can be introduced into a wound.

WO 2005/115523 and WO 2006/114638 disclose a wound dressing apparatus. In addition, WO 2006/114638 discloses an apparatus for aspirating, irrigating and / or cleaning a wound with at least one tube to allow irrigation and / or aspiration of the wound.

It is an objective of the present invention to mitigate, at least partially, the aforementioned problems.

It is an objective of the embodiments of the present invention to provide a method and apparatus that allow one or more agents such as analgesics, antibiotics and / or a wound irrigation to be introduced at the site of a wound without having to remove / replace a pano or a dressing covering the site of the wound.

It is an objective of the embodiments of the present invention to provide a method and apparatus that are capable of automatically supplying the agent continuously or at predetermined time intervals to the site of a wound.

It is an objective of the embodiments of the present invention to provide a method and apparatus that allow a user to quickly and efficiently deliver a highly accurate dose of medication or other such agent to the site of a wound.

The invention is as claimed in the claims.

According to a first aspect of the present invention, a method is provided for supplying at least one agent to the site of a wound, which comprises the steps of:

provide a supply tube that has an outlet at the site of a wound;

cover the wound site with a cloth; and

insert the agent into an outlet of the agent inlet supply tube, passing the agent along the supply tube through or below the pan to the site of the wound.

The invention comprises, in part, a joint apparatus for the provision of PNT therapy to a patient in almost any environment. The device is light, it can be powered by the electric network or by a battery using a rechargeable battery contained in a device (hereinafter, the term "device" is used to connote a unit that can contain all control means, source of feeding, recharging the power supply, electronic indicators and means to initiate and sustain the functions of aspiration of a wound and any additional necessary functions of a similar nature). For example, when you are away from home, the device may allow a prolonged period of operation with the energy of the batteries, and in the home, for example, the device may be connected to the mains by means of a charging unit while it is still being used and operated by the patient.

The joint apparatus of which the present invention is a part comprises: a dressing covering the wound and sealing at least one open end of a suction duct to a cavity formed on the wound by the dressing; an aspiration tube comprising at least one light passing through it leading from the wound dressing to a container of waste material to collect and contain exudates from the wound / waste material before disposal; and an energy feeding device, control and initiation and maintenance of the aspiration associated with the waste container.

The dressing covering the wound can be any type of dressing normally used with PNT therapy and, in very general terms, it can comprise, for example, a self-adhesive flexible semipermeable pano material, as is known in the dressing technique, for cover the wound and seal with the surrounding healthy tissue to create a sealed cavity or void on the wound. It may be appropriate that there is a porous barrier and support member in the cavity between the wound bed and the covering material to allow a homogeneous vacuum distribution to be achieved over the wound area, the porous barrier being a member of support, for example, a gauze, a foam, an inflatable bag or a known material of the type that makes contact with wounds resistant to crushing under the vacuum levels created and which allows the transfer of exudates from the wound crossing the wound area up to the suction duct sealed to the flexible cover pano over the wound.

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The suction duct can be a simple flexible tube that has, for example, a single light that passes through it and made of a compatible plastic material, for example, with a tissue in live meat. However, the suction duct may have several lights that pass through it to achieve specific objectives related to the invention. A portion of the tube located in the sealed cavity on the wound may have a structure to allow continued aspiration and evacuation of the exudates from the wound without being strangled or blocked or following the highest levels of the contemplated range of negative pressure.

It is contemplated that the negative pressure range for the apparatus that implements the present invention may be between about -6.67 kPa and -26.66 kPa (note that these pressures are relative to the normal ambient atmospheric pressure; thus -26.66 kPa indicates approximately 74.66 kPa in practice). It may be appropriate that the pressure range is between about -10 kPa and -20 kPa. Alternatively, a pressure range of up to -10 kPa, up to -10.67 kPa or above -10.67 kPa can be used. It may also be appropriate to use a pressure range below -10 kPa. Alternatively, a pressure range above -13.33 kPa or above -20 kPa could be used.

The suction duct can be connected by its remote distal end with respect to the dressing to the waste container by an intake socket or connector. The device containing the means for initiating and sustaining the wound or dressing expiration may be located between the dressing and the waste container; however, in a preferred embodiment of the apparatus that implements the present invention, the device can aspirate the wound or dressing through the container; thus, the waste container may preferably be located between the wound or the dressing and the device.

Preferably, the suction duct of waste material at the end of the container can be bonded with adhesive to the waste container to prevent unintentional detachment when, for example, it is caught in an obstruction.

The container can be a molding of plastic material or a composite unit comprising several separate moldings. It may be appropriate for the container to be translucent or transparent to visually determine the degree of filling with exudates. However, in some embodiments the container and the device may provide an automatic warning of an imminent filling condition of the container and may also provide means for cessation of aspiration when the container reaches the full condition.

The container may be equipped with a filter to prevent the escape of liquids and odors from it, and also to prevent the expulsion of bacteria into the atmosphere. Some filters may comprise several filters in series. Examples of suitable filters may comprise hydrophobic filters of, for example, a pore size of 0.2 pm, with respect to the sealing of the container against the expulsion of bacteria, and 1 pm against the expulsion of liquids.

It may be appropriate that the filters are located in an upper portion of the waste container in normal use, that is, when the apparatus is being used or transported by a patient, the filters are in an upper position and separated by gravity of the liquid from the exudate. in the waste container. In addition, such orientation keeps the outlet or outlet outlet of the waste container away from the surface of the exudate.

It may be appropriate that the waste container is filled with an absorbent gel, such as, for example, ISOLYSEL (trade mark) as a safeguard added against the leakage of the container when it is filled and replaced for disposal. Added advantages of a gel matrix in the storage volume of the waste container exudate are that it prevents excessive movement of the liquid, such as its inclination, minimizes bacterial growth and minimizes odors.

The waste container may also be provided with suitable means to prevent leakage thereof both when it is released from the device unit and also when the suction duct from the wound site or the dressing is released.

The container can have adequate means to prevent emptying by a user (without tools or damage to the container), so that a full container or at the end of its life for other reasons can only be removed with the waste fluid still contained in he.

The device and the waste container may have mutually complementary means for connecting a device unit to a waste container, whereby the suction means in the device unit is automatically connected to a drain socket in the waste container, so that there is a continuous aspiration path from the wound site or the dressing to an exhaust outlet in the device.

It is appropriate that the exhaust outlet of the fluid path through the apparatus is provided with a filter means to prevent unpleasant odors from releasing into the atmosphere.

In general terms, the device unit comprises an aspirating pump; a means for monitoring the pressure applied by the aspirating pump; a flowmeter to monitor the fluid flow through the aspirating pump; a control system that controls the suction pump in response to signals from sensors

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such as the means for monitoring the pressure and the flowmeter, for example, and a control system that also controls a feed management system with respect to a built-in batt and the load thereof and, finally, a system of user interface by means of which various functions of the device, such as, for example, the reference value of the pressure level (including stopping and starting the device), can be set by a user. The device unit may contain all of the above features within a single unified housing.

In view of the fact that the device unit contains in it the majority of the internal cost of the equipment, ideally it can also survive impacts and tolerate cleanliness to be reusable by other patients.

In terms of pressure capacity, the aspiration medium may be able to apply a maximum pressure coffee of at least -20.66 kPa to the site of a wound or to the dressing. The apparatus is capable of maintaining a predetermined negative pressure even in conditions where there is a small leak of air into the system and a high flow of exudate.

The pressure control system can prevent the minimum pressure achieved from exceeding, for example, -26.66 kPa so as not to cause undue discomfort to the patient. The required pressure can be regulated by the user at various differentiated levels, such as, for example, -6.67, -10, -13.33, -16.67, -20, -23.33 kPa, depending on the needs of the wound in question and the advice of a chemist. Thus, in use, suitable pressure ranges may be between -3.33 and -10.67 kPa, or between -6.67 and -10.13 kPa, or between -6.67 and -10 kPa as examples. The control system may also be able to advantageously maintain the pressure set within a tolerance band of +/- 1.33 kPa of the reference value for 95% of the time the device is operating, given that leakage rates and of exudation are within the expected or normal levels.

It is appropriate that the control system can activate alarm means such as a flashing light, a bell or any other suitable means when various abnormal conditions occur, such as: pressure outside the reference value in a large amount due to a large leak of air inside the system; the suction pump is too high due to a relatively minor air leak inside the system; pressure difference between the wound site and the pump that is too high due, for example, to an obstruction or the waste container being full.

The apparatus of the present invention may be provided with a carrying case and a suitable support means, such as, for example, a belt or a harness. The transport case may be adapted to conform to the shape of the apparatus included in the device and the waste container joined together. In particular, the transport case can be provided with a bottom flap that opens that allows the waste container to be changed without the complete removal of the device from the transport case.

The carrying case can be provided with an opening covered by a movable flap to allow the user access to a keyboard to vary the therapy applied by the apparatus. So that the present invention can be more fully understood, examples will now be described, by way of illustration only, with reference to the attached drawings, in which:

Figure 1 shows a generalized schematic block diagram showing an overview of an apparatus and the features of the constituent apparatus thereof;

Figure 2 shows a generalized schematic block diagram similar to Figure 1 and showing fluid paths therein;

Figure 3 shows a generalized schematic block diagram similar to Figure 1, but only of a device unit and showing energy paths for the various characteristics of energy consumption / production of the apparatus;

Figure 4 shows a generalized schematic block diagram similar to Figure 3 of the device unit and showing the data tracks of the control system for controlling the various components and functions of the apparatus;

Figure 5 shows a perspective view of an apparatus;

Figure 6 shows a perspective view of an assembled device unit of the apparatus of Figure 5;

Figure 7 shows an exploded view of the unit of the device of Figure 6;

Figure 8 shows a partially sectioned side elevational view through the contact surface between

a waste container and the device unit of the apparatus;

Figure 9 shows a cross-section through a waste container of the apparatus of Figures 5 to 8; Figure 10 illustrates the site of a wound;

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Figure 11 illustrates an alternative wound site; Figure 12 illustrates how a supply tube can be fixed to a pano; Figure 13 illustrates an attachable supply tube between two loops; Figure 14 illustrates a supply tube; Y

Figure 15 illustrates the supply tube shown in Figure 14 placed at the site of a wound.

Reference is now made to Figures 1 to 4 of the drawings, and the same or similar features are denoted by common reference numbers.

Figure 1 shows a generalized schematic view of an apparatus 10 of a portable topical negative pressure (PNT) system. It will be understood that the embodiments of the present invention are generally applicable to use in such a PNT system. Briefly, the therapy of wounds with negative pressure contributes to the closure and healing of many forms of wounds "difficult to heal" reducing tissue edema; promotes blood flow and granular tissue formation; Eliminates excess exudates and can reduce bacterial load (and, therefore, infection). In addition, the therapy allows a minor alteration of a wound, which leads to faster healing. The PNT system is presented in more detail later, but, in summary form, it includes a portable body that includes a container and a device, the device being able to provide a prolonged period of continuous therapy in a useful life of at least one year. . The system is connected to a patient by a tube section with one end of the tube operatively fixed to a wound dressing in the patient.

More particularly, as shown in Figure 1, the apparatus comprises an aspiration duct 12 operatively connected to a dressing 14, and a surface thereof tightly connected thereto. The dressing 14 will not be described further here except to say that it is formed in a known manner from materials well known to those skilled in the art of dressing to create a sealed cavity on and around a wound to be treated by PNT therapy with the apparatus of the present invention. The suction duct has a line connector 16 comprising portions 18, 20 of connector halfway along its length between the dressing 14 and a waste container 22. Although the fluid path through the conduit portions 12 and 24 to the waste container is continuous, the aspiration conduit between the connector portion 20 and the container 22 is denoted by a different reference number, 24: portions 18 , 20 connector are attached to conduit portions 12, 24 in a leak-free, but disconnectable manner. The waste container 22 is provided with filters 26 that prevent the escape of liquid and bacteria through an outlet 28 from the waste container. The filters may comprise a 1 pm hydrophobic filter for liquids and a 0.2 pm filter for bacteria, so that all liquid and all bacteria are confined in an internal waste collection volume of the waste container 22. The outlet 28 of the waste container 22 is coupled with an inlet / suction socket 30 of a device unit 32 by means of mutually sealing connector portions 34, 36 that are automatically coupled and sealed to each other when the container 22 debris is connected to the unit 32 of the device, the waste container 22 and the unit 32 of the device being held together by holding sets 38, 40. The unit 32 of the device comprises an aspirating pump 44, an aspirating pressure monitor 46 and an aspirating flowmeter 48 operatively connected to each other. The suction line takes the aspirated fluid, which in the case of the fluid on the outlet side of the outlet socket 28 is gaseous, through a silencer system 50 and an end filter 52 having an activated carbon matrix, which ensures that no odor escapes with the gas expelled from the device 32 through an exhaust outlet 54. The material of the filter 52 also serves as a noise reducing material to improve the effect of the silencer system 50. The device 32 also contains a baton 56 to feed the apparatus, a baton that also feeds the control system 60 that controls an interface system 62 of user controlled by a keyboard (not shown) and the suction pump 44 by means of signals from the sensors 46, 48. A feed management system 66 is also provided that controls the feed from the baton 56, the recharge of the same and the energy requirements of the suction pump 44 and other electrically operated components. An electrical connector 68 is provided to receive a power input plug 70 from an ultra-low safety voltage supply (SELv) source 72 connected to a mains supply 74 when the user of the apparatus or the apparatus itself is adjacent to a Convenient wall outlet power supply.

Figure 2 shows a schematic representation similar to Figure 1, but shows the fluid paths in greater detail. The wound exudate is aspirated from the site of the wound or the dressing 14 through the conduit 12, the two connector portions 18, 20 and the conduit 24 into the waste container 22. The waste container 22 comprises a relatively large volume 80, around 500 ml, to which the exudate from the wound is aspirated by the aspiration system in an inlet socket 82. The fluid 84 aspirated into the volume 80 of the container is a mixture of both the air sucked into the dressing 14 through the semipermeable adhesive sealed (not shown) and the liquid 86 in the form of wound exudates. The volume 80 inside the container is also at a reduced pressure and the gaseous element 88 of the aspirated fluids is expelled from the volume 80 of the container through the filters 26 and the exhaust outlet 28 of the waste container as a bacteria free gas. From the outlet 28 of the waste container to the final outlet 54, the fluid is only gaseous.

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Figure 3 shows a schematic diagram showing only the portion of the device of the apparatus and the ways of ene ^ a in the device of the apparatus that implements the present invention. Energy is provided primarily by the baton 56 when the user is away from home or his workplace, for example; however, energy can also be provided by an external charging unit 72 powered by the electrical network 74 which, when connected to the device 32 by the wall socket 68, is capable of both operating the device and recharging the drum 56 simultaneously. The power management system 66 is included so that it can control the power of the PNT system. The PNT system is a rechargeable battery powered system, but it is capable of working directly with the electricity of the grid, as will be described in greater detail later with respect to the subsequent figures. If disconnected from the mains, the battery has enough charge stored for approximately 8 hours of use under normal conditions. It will be appreciated that bats can be used that have other durations associated between refills. For example, bats can be used that provide less than 8 hours or more than 8 hours. When connected to the power grid, the device will work with the power of the power grid and, simultaneously, recharge the battery if it is depleted by its portable use. The exact speed of recharge of the battery will depend on the load of the PNT system. For example, if the wound is very large or there is a significant leak, recharging the baton will take longer than if the wound is small and well sealed.

Figure 4 shows the device 32 part of the apparatus that implements the present invention and the data lines used in the control system for the control of the suction pump and other features of the apparatus. A key purpose of the PNT system is to apply negative pressure therapy to wounds. This is achieved through the pressure control system, which includes the pump and a pump control system. The pump applies a negative pressure; the pressure control system gives information on the return to the control system about the pressure in the pump head; Pump control varies the speed of the pump depending on the difference between the target pressure and the actual pressure at the pump head. To improve the accuracy of the pump speed and, therefore, provide a more uniform and more precise application of the negative pressure at the site of a wound, the pump is controlled by an auxiliary control system. From time to time, the pump is allowed to go "free" during its work cycle by disconnecting the voltage applied to it. The motor, which continues to spin, causes a “retrograde electromotive force” or FEMR to be generated. This FEMR can be monitored and can be used to provide an accurate measurement of the pump speed. Thus, the speed can be regulated more precisely than the prior art systems can.

According to embodiments of the present invention, the actual pressure at the site of a wound is not measured, but the difference between a measured pressure (at the pump) and the pressure of the wound is minimized by the use of large filters and tubes. great diameter whenever practical. If the pressure control measures that the pressure in the pump head is greater than a target pressure (closer to the atmospheric pressure) over a period of time, the device sends an alarm and presents a message that alerts the user of a potential problem, such as a leak.

In addition to pressure control, a separate flow control system can be provided. A flowmeter can be placed after the pump and used to detect when a container is full or the tube has become clogged. If the flow falls below a certain threshold, the device sounds an alarm and presents a message that alerts the user of a potential shutter or a full container.

Reference is now made to Figures 5 to 9, which show various views and cross sections of a preferred embodiment of the apparatus 200, which implements the present invention. The preferred embodiment is generally oval in plan and comprises a device unit 202 and a waste container 204 connected to each other by fastening arrangements 206. The unit 202 of the device has a liquid crystal display (LCD) 208 that gives text mode return information about the therapy applied to the wound, and a membrane keyboard 210, the LCD being visible through the keyboard membrane to allow the user to adjust or regulate the therapy to be applied to the wound (not shown). The device has a lower face 212, generally transverse, in the center of which there is a spout 214 forming the suction / inlet socket 216 to which the suction means (which are to be described later) are connected within the device unit. The lower edge of the device unit is provided with a recessed male matching peripheral face 218 that engages with a cooperating peripheral female formation 220 on an upper edge of the waste container 204 (see Figures 8 and 9). On each side of the device 202, clamps 222 articulated to the container 204 have a coupling one (not shown) that cooperates with the formations in the recesses 226 of the body of the device unit. In Figure 7 it can be seen that the housing 230 of the device unit has, to a large extent, a collapsible construction comprising, respectively, front and rear moldings 232, 234 and left and right side inserts 236, 238. Inside the housing 230 there is a central chassis 240 which is attached to a molded internal structural member 242, which acts as a mount for the circuit and the electrical components and also retaining the base 246 and the unit 248 of the suction pump. Various sections 250, 252, 254 of tube connect the pump unit 248 and the suction / inlet socket 216 to a final gas leak through a filter 290. Figure 8 shows a partially sectioned side elevation of the apparatus 200, being the partial section around the joint between the device unit 202 and the waste container 204, a cross section of which is shown in Figure 9. These views show the lowered edge 218 of the male formation of the cooperating device unit with the female portion 220 defined by a vertical flange 260 around the upper face 262 of the waste container 204. When the waste container is

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attaches to the unit of the device, the spigot 214, which has a toric joint 264 around it, is tightly coupled with a cylindrical portion 266 of tube formed around an outlet / outlet 268 of the waste container. The spout 214 of the device is not fixedly attached to the casing of the device, but is allowed to "float" or move in its location features in the casing to allow the spigot 214 and the seal 264 to move, forming the best joint sealed with the hole in the cylindrical portion 266 of the tube in the connection of the waste container to the unit of the device. In Figure 9 the waste container 204 is shown in a vertical orientation, in the same way it is when carried by a user. Thus, any exudate 270 is at the bottom of the internal volume of portion 272 of the waste receptacle. There is a suction conduit 274 permanently fixed to an inlet tap 278 that defines an inlet 280 to receive fluid aspirated from a wound (not shown) through the conduit 274. Filter members 282 (comprising a 0.2 pm filter) and 284 (comprising a 1 pm filter) together with a filter retention molding 286 adjacent to a closure member or upper cap 288, the filter members preventing any liquid or any bacteria from being aspirated out of the outlet exhaust 268 into the pump and the suction line through an exhaust unit 290 and filter, which is connected to a housing outlet molding in 291 through a tube Exhaust (not shown) on the side piece 236 of the housing. The side pieces 236, 238 are provided with recesses 292 having support pins 294 therein to place a transport strap (not shown) for use by the patient. The side pieces 230 and the container 204 are also provided with features that prevent the container and the device from presenting a mutual "wobble" when connected to each other. There are ribs (not shown) extending between the upper closing member 288 of the container. and the inner face 300 of the vertical flange 260 located in grooves 302 on the side walls of the device when the container and the device are connected. The housing 230 also houses the entire electrical equipment and control and the power management features, the operation of which was briefly described above with respect to Figures 3 and 4. The side piece 238 is provided with a socket member 298 to receive a recharge plug from an external battery charger powered by the mains (neither shown).

It will be appreciated that the bacterial load of the wounds may increase over time and that the wounds, unless an evasive action is taken, may dry while undergoing negative pressure therapy for wounds (TPNH). This happens when conventional wound dressings are used. Figure 10 illustrates a way in which the bacterial load of a wound can be reduced or eliminated according to embodiments of the present invention. It will be appreciated that embodiments of the present invention can also be used to prevent wounds from drying out and / or to relieve localized pain and / or to introduce antibiotics and / or to provide wound irrigation at the site of a wound.

As illustrated in Figure 10, site 1000 of a wound includes a bed 1001 of wound in a layer 1002 of a patient's skin. A drain 1003 is fixed to a distal end of the suction duct 12 by means of a connector. The drain is sealed to the dressing, so that a reduced pressure on the wound can be maintained using a pano and other such sealing means. A gauze 1004 or other filling mechanism may be used at the site of the wound to pad the area under the pan 14.

A generally T-shaped supply tube 1005 extends across the pano 14. The extension of the supply tube through the pano can be achieved either by providing a dressing as an inlet (not shown) sized to accommodate the diameter of the tube of supply or by squeezing the pano 14 around the supply tube during the wound site bandage. The supply tube 1005 includes an agent inlet 1006 through which the agent can be introduced.

It will be appreciated that embodiments of the present invention can be used to deliver a wide variety of agents to the wound site. For example, but not exclusively, the embodiments of the present invention may provide a powder or fluid medicament and / or an analgesic and / or antibiotic medication and / or saline solution and / or hydrating fluid and / or biologically active agents and / or growth factors and / or enzymes and / or anti-inflammatories. Embodiments of the present invention can also be used to introduce a mixture of agents. When the agent is introduced by the inlet valve 1006, it passes through the supply tube through the pan to the site of the wound, entering the site of the wound through an outlet 1007.

The supply tube 1005 is also provided with a removable plug 1008 that can tightly plug the end of the supply tube. When an agent is to be introduced at the site of the wound, cap 1008 must be removed to reveal a filter 1009 that is provided to allow, as desired, air to fill the wound. The air allows the injection to be washed and contributes to the removal of large volumes of fluid from the wound.

As illustrated in Figure 10, the agent can be introduced at the wound site using a syringe 1010 containing a predetermined amount of the agent to be introduced. The syringe is placed in the side tube of the supply tube with the required solution and then a Hoffman 1011 screw clamp or other such inlet valve is released. Cap 1008 is removed and then the fluid or dry agent is injected into the wound. When a predetermined amount of the agent has been introduced, the cap can be placed back on the filter and reapplied the Hoffman screw clamp. Then the syringe can be removed. TPNH can then be applied to the wound. Alternatively, the TPNH can continue while the agent is introduced.

Figure 11 illustrates an alternative embodiment of the present invention in which the agent is introduced at the site of a wound from a reservoir 1100 containing agent 1020, such as moisturizing fluid. The agent 1020 can be released from the tank by a mechanical system 1101 for time-release arranged to periodically open a valve 1102 to release agent in the supply tube. Those skilled in the art will appreciate that any other type of release system could be used for the tank 1010. For example, but not exclusively, a timed release electric system could be used, or the supply tube 1005 could be connected to the tank by through a hole or several holes, each of which has a predetermined size to effectively drip the agent into the area of the wound bed. Alternatively, the valve can be kept open continuously.

10 Figure 12 illustrates an alternative embodiment of the present invention in which the supply tube 1200 has a substantially discoidal base section 1201 from which a vertical tube 1202 extends. A side tube 1203 branches off the vertical one 1202 and has an inlet 1204 of the agent controlled by an inlet valve 1205. It will be appreciated that agents can be introduced through the inlet 1205 and the inlet valve 1205, as described with the previous embodiments. The socket 1204 can be protected by a partition not shown.

Also, the vertically extending supply tube 1202 has a filter 1206 in an upper housing 1207. An opening 1208 allows air to enter the supply tube when an air inlet valve 1209 is open. A plug (not shown) can plug the supply tube tightly again 1208.

A lower surface 1210 of the body 1201 of the supply tube has an adhesive layer 1211 that is covered 20 by the protective paper 1212. As will be described later herein, the protective paper 1212 can be detached to reveal the adhesive.

A penetrating portion 1213 of the supply tube extends below a low surface of the discoidal body 1201. The protrusion extends below this lower surface at a sufficient distance, so that a pano 14 can penetrate when the supply tube It is mounted in a sealed dressing.

The supply tube shown in Figure 12 provides a socket that can be connected to a PNT dressing to provide access to the wound agents. To connect the supply tube, the sealing layer of the PNT dressing, here called pano, is perforated to create a small hole of adequate size to accept the small projection of the conduit on the underside of the device. The protective layer 1212 is removed, exposing the pressure sensitive adhesive layer. Next, the device is positioned so that the protrusion aligns with the perforated hole in the sealing means and a force is applied to ensure that a good seal is formed with the adhesive. The supply tube may be made of any substantially nigged material, but it may be appropriate to use a flexible polymeric material having a normal Shore hardness of 50-70A: for example, silicone, PVC, polyurethane or the like. In addition, input 1204 may include an accessory to allow connection of a device such as a syringe or a reservoir, as will be appreciated by those skilled in the art.

Figure 13 illustrates an alternative embodiment of the present invention similar in many ways to that shown in Figure 12, but in which the lower portion 1300 of the base includes a substantially conical central zone 1301 that flares outwardly into a 1302 thinner discoidal zone. The thinness of the discoid area 1302 means that the supply tube can be fixed between two sealing pins of a dressing. The top 40 is illustrated as pano 1305, which is a disc with a central hole. To this end, protective paper 1303 is provided to cover a lower surface of an adhesive layer 1304 that is adhered by an end proximal to a surface greater than the discoidal portion 1302 of the supply tube. An upper surface of the adhesive layer 1304 is covered by the pano 1305. Optionally, the pano 1305 may have an additional film (not shown) on top of it to reinforce the pano 1305 during its assembly with the dressing. The film 45 can be removed once the pano 1305 is firmly placed.

To fix the supply tube in a dressing, a small hole is first perforated in a lower sealing layer, the removable paper having been removed, and then the supply tube is pushed into the lower pan so that the projection 1213 extends through the cloth. The supply tube is fixed to the bottom pan by means of the bottom surface of the adhesive layer 1304.

Figure 14 illustrates an alternative embodiment of the present invention in which a supply tube 1400 has a pill-shaped base section 1401, from which a vertical tube 1402 extends. A side tube 1403, which contains the partition wall self-sealing 1406, branches off the main tube 1402 and has an air inlet 1404 and a pathogen filter 1405. It will be appreciated that agents can be introduced through partition wall 1406 by inserting a hypodermic needle attached to a pre-filled syringe with agents, as described hereinbefore with respect to previous embodiments.

Figure 15 illustrates how the supply tube 1400 illustrated in Figure 14 can be placed between a main pano 1501 and an auxiliary pano 1502. As shown in Figure 15, the supply tube of this embodiment tends to be located laterally against the site of a wound The use of main pano 1501 and auxiliary pano 1502,

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which form a flap 1503, means that the supply tube and portions of the main and auxiliary panels are removable. This makes it easier to put coverage, and it can be more comfortable for a patient. In addition, instead of the supply tube extending outward from the site of a wound, the tube will be substantially flat so that the accidental alteration of the supply tube is kept at a minimum. This is particularly useful when the supply tube is used continuously as part of a drip process.

To place the supply tube 1400 at the site of a wound, auxiliary pan 1502 is adhered to a target surface near site 1000 of the wound. A terminal zone 1504 of the auxiliary pan 1502 folds backwards, forming a fold line 1505. The upper surface 1506 is adhesive, and the tablet-shaped portion of the supply tube 1402 can adhere to this upper surface. Next, the main pano 1501 is placed on the wound site covering the terminal zone 1504 of the auxiliary pano. A lower surface 1507 of the main pan is adhesive so that the main pan and auxiliary pan can be pressed together around the tablet-shaped base portion of the supply tube 1400. Consequently, the flap 1503 is formed, which can move in an articulated manner around the bending line 1505.

It will be appreciated that additional passageways (not shown) can be formed through the tablet-shaped section of the supply tube 1400 to provide additional entry and exit access to the wound site.

Those skilled in the art will appreciate that, according to embodiments of the present invention, instead of connecting a syringe or a reservoir to the supply tube, the supply tube can be directly connected to an outlet of a physiological serum dropper so that the wound bed may be continuously irrigated.

It will also be appreciated that occasionally using the syringe illustrated more clearly in Figure 10, fluid may be drawn from the area of the wound bed for sampling.

Provision of a passage through pano 14 or under the pano means that, from time to time, a fluid or dry agent can be introduced at the site of a wound without the need to move the dressing. This means that a localized analgesic and / or antibiotics and / or wound irrigation can be introduced at the site of a wound without the need for a regular change of dressing. This can contribute to preventing tissue infection, reduces cost, reduces pain to the patient and reduces the risk of infection among patients. It will also be appreciated that, from time to time, embodiments of the present invention allow the wound fluid to be aspirated from the wound bed again without the need to alter the picture 14 covering the wound dressing, thereby avoiding certain associated disadvantages. with the bets of the prior art.

The embodiments of the present invention allow the agent to be introduced continuously or at predetermined time intervals at the site of a wound or that the wound fluid is aspirated from the site of the wound either while continuing therapy with topical negative pressure of the wound. or in a way that the PNT can be minimized.

Throughout the description and claims herein, the words "understand" and "contain" and variations of the words, for example "understanding" and "understand", mean "including without limitation", and are not intended to exclude ( nor do they) other remains, additives, components, whole numbers or stages.

Throughout the description and claims in this report, the singular encompasses the plural, unless the context requires something different. In particular, when an indefinite article is used, it should be understood that memory contemplates plurality as much as singularity, unless the context requires something different.

It is to be understood that the features, integers, features, compounds, moieties or chemical groups described together with a particular aspect, embodiment or example are applicable to any other aspect, embodiment or example described herein, unless they are incompatible with them.

Claims (12)

5 10 fifteen twenty 25 30 35 1. An apparatus for supplying at least one agent to the site of a wound, comprising: a pano (14, 1305, 1501, 1502) to cover the site of a wound; and a supply tube (1005, 1202, 1400) comprising a substantially T-shaped portion (1203, 1403) comprising an outlet (1007), an agent inlet (1006, 1204) and a socket (1208 , 1404) air inlet; wherein the air inlet (1208, 1204) comprises an air filter (1009, 1206, 1405), characterized in that the air inlet (1208, 1404) allows the air inlet (1006, 1204) Agent inlet is washed and contributes to the removal of large volumes of fluid from the wound. 2. The apparatus claimed in Claim 1, which further comprises: an inlet valve (1011, 1102, 1205) downstream of the agent inlet and / or a self-sealing partition (1406) in the agent inlet. 3. The apparatus claimed in Claim 2 wherein the inlet valve comprises a Hoffman screw clamp. 4. The apparatus claimed in any one of Claims 1 to 3 which further comprises: a releasable plug (1008) connected to the air intake. 5. The apparatus claimed in any one of Claims 1 to 4, further comprising: a syringe (1010) connectable to the inlet of the agent. 6. The apparatus claimed in any one of Claims 1 to 4 which further comprises: a reservoir (1100), which has an outlet orifice, connectable to the agent inlet. 7. The apparatus claimed in Claim 6 wherein, in addition, the reservoir comprises: a mechanical or electrical time release system. 8. The apparatus claimed in any one of Claims 1 to 7 wherein, in addition, the pano comprises: a socket ready to receive a portion of the supply tube and seal against it. 9. The apparatus claimed in any one of Claims 1 to 7, which further comprises: a discoidal portion (1201, 1300, 1302) of body extending outwardly around an outlet area of the supply tube. 10. The apparatus claimed in Claim 9, which further comprises: at least one adhesive layer (1211, 1304) in the discoidal portion of the body. 11. The apparatus claimed in Claim 9, which further comprises: a penetrating portion (1213) that extends from a lower surface of the discoidal portion of the body. 12. The apparatus claimed in any one of Claims 1 to 11 which, furthermore, comprises: a PNT system comprising a drain (1003) that can be placed under the pan at the site of the wound.